APPLICATION
ANDA040486
TYPE
ANDA
ORIGINAL APPROVAL
2015-02-27
LATEST ACTION
2025-05-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METAXALONEPrescription
METAXALONE 400MG · TABLET · ORAL
Approval history
2025-05-23Labeling · Supplement 15 · standardAP
2019-10-07Labeling · Supplement 7 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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